FDA Approves First Generics Of Osteoporosis Drug Boniva

The Food and Drug Administration March 19 approved the first generic versions of Roche’s Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture, the agency said. FDA said the manufacturers that have gained approval to market generic 150 mg ibandronate tablets are Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc.

“Men as well as women are affected by osteoporosis, a disease that can be prevented and treated,” said Keith Webber, deputy ...